NL-OMON55317
Completed
Phase 3
A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12) - PIVOT-12
ektar Therapeutics0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- ektar Therapeutics
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provide written, informed consent to participate in the study and follow the
- •study procedures. The Investigator takes responsibility for ensuring that all
- •vulnerable patients are protected and participate voluntarily in an environment
- •free from coercion or undue influence. (See Section 5\.2 for details about
- •obtaining informed consent for adolescent patients.)
- •2\. Male or female patients age 18 years or older at the time of signing the
- •informed consent form (ICF) (age 18 years or older where local regulations or
- •institutional policies do not allow for patients \< 18 years of age to
- •participate).
- •3\. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance
Exclusion Criteria
- •1\. Use of an investigational agent or an investigational device within 28 days
- •before randomization.
- •2\. Female patients who are pregnant or lactating, who plan to get pregnant, or
- •who have a positive serum or urine pregnancy test.
- •3\. History of ocular/uveal melanoma or mucosal melanoma.
- •4\. Active, known or suspected autoimmune disease. Patients with Type I diabetes
- •mellitus, hypothyroidism only requiring hormone replacement, skin disorders
- •(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or
- •conditions not expected to recur in the absence of an external trigger are
- •permitted to enroll.
Outcomes
Primary Outcomes
Not specified
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